Yoga in Treating Sleep Disturbance in Cancer Survivors

Brief Summary

Official Title: “Yoga for Persistent Sleep Disturbance in Cancer Survivors”

RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors.

PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in cancer survivors.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care
  • Study Primary Completion Date: April 2013

Detailed Clinical Trial Description

OBJECTIVES:

Primary

- Determine the efficacy of Hatha yoga in improving sleep quality in cancer survivors experiencing persistent sleep disturbance.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender and sleep disturbance rating reported on the eligibility assessment questionnaire (≤ 5 vs > 5). Patients are randomized to 1 of 2 arms.

- Arm I: Patients receive standard care for 6 weeks. Patients may switch to the yoga intervention immediately after study completion.

- Arm II:Patients receive standard care for 2 weeks, followed by two 75-minute sessions of Hatha yoga per week for 4 weeks.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Interventions Used in this Clinical Trial

  • Procedure: Standard Care Control Condition
    • Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.
  • Procedure: Yoga Intervention (YOCAS)
    • The Yoga for Cancer Survivors (YOCAS) intervention uses two forms of yoga: Gentle Hatha yoga and Restorative yoga. The YOCAS sessions are standardized, and each session includes physical alignment postures, breathing and mindfulness exercises. The intervention is delivered in an instructor taught, group format, twice a week for 75 minutes each time over 4 weeks for a total of eight sessions of yoga. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Yoga Intervention (YOCAS)
    • Standardized Yoga for Cancer Survivors (YOCAS)
  • Experimental: Standard Care Control Condition
    • Standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses.

Outcome Measures for this Clinical Trial

Primary Measures

  • Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)
    • Time Frame: 2-24 months after surgery, chemotherapy, and/or radiation therapy
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Diagnosis of any type of cancer
  • More than 1 primary cancer allowed
  • Has undergone and completed all forms of standard treatment (surgery, chemotherapy, radiation therapy) within the past 2 to 24 months
  • Patients can be on hormones such as Tamoxifen, or monoclonal antibodies like Herceptin
  • Persistent sleep disturbance, as indicated by a response of ≥ 3 when asked to rate their sleep on an 11-point scale (0 is equivalent to no sleep disturbance and 10 is the worst possible sleep disturbance)
  • Able to read English
  • 21 years of age or older

Exclusion Criteria

  • No prior or concurrent regular (≥ 1 day/week) participation in yoga classes or maintain regular personal practice of any form of yoga within the past 3 months
  • No diagnosis of sleep apnea
  • No concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen citrate) or monoclonal antibodies (e.g., trastuzumab [Herceptin®])
  • No metastatic cancer

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Gary Morrow
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Gary Morrow, Director, URCC CCOP Research Base – University of Rochester
  • Overall Official(s)
    • Karen M. Mustian, PhD, Principal Investigator, University of Rochester

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00397930